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Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

Primary Purpose

Idiopathic Membranous Nephropathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring Idiopathic Membranous Nephropathy, Treatment, Tacrolimus, Cyclophosphamide

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Biopsy-proven idiopathic membranous nephropathy Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl Age 18-60 years with informed consent Exclusion Criteria: Patient with abnormal liver function tests Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days Active/serious infection Patient with hepatitis B surface antigen or who is hepatitis C antibody positive Patient who is diabetic Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Sites / Locations

  • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  • Research Institute of Nephrology, Jinling Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

FK506

Arm Description

Outcomes

Primary Outcome Measures

To explore the potential role of tacrolimus in the treatment of membranous nephropathy.

Secondary Outcome Measures

To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.

Full Information

First Posted
March 13, 2006
Last Updated
February 2, 2012
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00302523
Brief Title
Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
Official Title
Tacrolimus Treatment of Patients With Idiopathic
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is: To explore the potential role of tacrolimus in the treatment of membranous nephropathy. To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.
Detailed Description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy
Keywords
Idiopathic Membranous Nephropathy, Treatment, Tacrolimus, Cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FK506
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Tacrolimus,Prograf
Intervention Description
FK506,0.1mg/kg/d
Primary Outcome Measure Information:
Title
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Biopsy-proven idiopathic membranous nephropathy Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl Age 18-60 years with informed consent Exclusion Criteria: Patient with abnormal liver function tests Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days Active/serious infection Patient with hepatitis B surface antigen or who is hepatitis C antibody positive Patient who is diabetic Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-hong Liu, M.D.
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Research Institute of Nephrology, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34778952
Citation
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Results Reference
derived

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Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

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